Safety and Efficacy of KSVCBD Injection in Autoimmune Diseases

Sponsor
Chinese PLA General Hospital
Study ID
NCT07613411
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Autoimmune Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • KSVCBD injection — DRUG
    KSVCBD injection is an in vivo CAR-T therapy targeting CD19/BCMA and is administered by IV infusion.

Study Details

KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This single-arm, open-label, early exploratory clinical study is designed to evaluate the safety and preliminary efficacy of KSVCBD injection in patients with Autoimmune Diseases.

Key Dates

First listed
May 29, 2026
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Autoimmune Diseases

Primary Outcome Measure

Dose limited toxicity (DLT) [ Time Frame: Within 28 days post-infusion ]

Central Contacts

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